My name is Marianne Brodmann. I am the Head of the Division of Angiology here at the Medical University in Graz, Austria.

What is the reasoning behind the study?

This study is a very relevant study because it's evaluating the database in the United States and then trying to find out, with regard to the outcome, if patients who have been treated with drug-eluting devices, either TCPs or stents, do worse or better than those who have not been treated with drug-eluting devices, plain old balloon angioplasty or bare-metal stents. And at the end of the day, it was a matching. They found out that a group of matched patients which they were able to compare to look for the outcome endpoints they have set up at the beginning.

What was the study design and patient population?

The patient population was from a real database which has been evaluated better and better, and these were all patients who had undergone PAD treatment with endovascular revascularisation. And they were then matched, pair matched and divided into patients who have received drug-eluting devices, paclitaxel-coated devices or non-drug-coated devices, non paclitaxel-coated devices.

What are the key outcomes?

The key outcome is that, with regard to the United States, more white patients got paclitaxel-coated, drug-eluting device treatment than compared for example to the black people population — first thing. Second thing was that patients with drug-eluting devices had a much better outcome with regard to amputation-free survival, amputation rates and mortality.

How should these findings impact clinical practice?

First of all, they should impact clinical practice in the way that we use drug-eluting devices, which have relevant data in all our patients when we do endovascular revascularisation, that we should go away from non-drug-coated devices alone as a treatment option — first thing. Second thing, it also adds to this safety question which has been raised in 2018 that paclitaxel is not safe on any of the devices and causes harm in PAD patients.

So this is, once again, another piece of science which is really stopping or helping to stop this kind of discussion and helps physicians to make them sure that they do the right thing if they use these drug-coated devices. And it has an impact on patient outcome; the outcome of patients is better when we use drug-coated devices.

What further research is needed in this area?

In this area, I mean the further research, what is needed is that if we have upcoming, other drug-eluting technologies, other drugs like limus or whatever, then we need to see if in certain devices limus has the same efficacy as paclitaxel.

This is the further research which is needed. Then it would be ideal to also have, once again, maybe in two or three years, a huge database where we can emulate this just for the limus space, or if there will be other drugs coming up, mixed drugs or whatever, then we need to do the same thing in the future.